Navigation Links
Sanofi Pasteur announces FDA approval of menactra meningococcal conjugate vaccine indication for infants

Swiftwater, PA April 22, 2011 - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has granted licensure to expand the indication for its meningococcal conjugate vaccine, Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), to include a two-dose schedule for infants and children 9 months through 23 months of age. This is the first U.S. approval of a meningococcal vaccine for this age group.

"Licensure of Menactra vaccine for infants as young as 9 months of age gives the opportunity to help protect infants against this potentially deadly disease when the likelihood of exposure supports a need for early protection," said Stephen I. Pelton, MD, Professor of Pediatrics and Epidemiology, Boston University Schools of Medicine and Public Health and Chief, section of Pediatric Infectious Diseases, Boston Medical Center.

Meningococcal disease is a rare but deadly disease caused by the bacterium Neisseria meningitidis. The disease can progress quickly and take the life of a child within 24 hours. Menactra vaccine was the first quadrivalent conjugate vaccine licensed in the United States for active immunization against meningococcal disease caused by the serogroups contained in the vaccine (A, C, Y and W-135). More than 36 million doses of Menactra vaccine have been distributed in the United States since its licensure in 2005.

The FDA approval of Menactra vaccine for infants was based on results of one Phase II and three Phase III modified single-blind, controlled, multicenter trials in which more than 3,300 infants from the United States received Menactra vaccine using a two-dose schedule, starting as young as 9 months of age. Results from these studies showed that 2 doses of Menactra vaccine given 3 months apart elicit a robust immune response against the serogroups included in the vaccine. The studies also showed that measles-mumps-rubellavaricella vaccine (MMRV) and pneumococcal conjugate vaccine (PCV7) can be administrated concomitantly with Menactra vaccine in children. Vaccine related reactions included swelling, tenderness at injection site, and irritability.

"The approval of Menactra vaccine for infants is a significant advancement toward potentially eliminating the threat of this serious disease in this vulnerable population for included serogroups," said Michael Decker, MD, MPH, vice president, scientific and medical affairs at Sanofi Pasteur. "With this approval, it is now possible to help protect persons from 9 months through 55 years of age."


Contact: Amy Ba
Cooney Waters Group, Inc.

Related medicine news :

1. Eggs Being Produced by Recall Farms Safe, if Pasteurized, Experts Say
2. Government of Canada announces results in fight to save women and children with malaria
3. Oxford Nanopore announces licence agreement with Harvard University for graphene DNA sequencing
4. Elsevier Health Middle East announces publication of first bilingual medical title
5. International Vaccine Institute announces launch of Dengue Vaccine Initiative
6. Washington Life Sciences Discovery Fund announces grants to commercialize promising technologies
7. MSD Wellcome Trust Hilleman Laboratories announces first project
8. AIUM announces ultrasound practice accreditation in fetal echocardiography
9. American Physical Society announces Physical Review X
10. Beth Israel Deaconess Medical Center announces new AAAS Fellows
11. NARSAD announces $12.6 million for new generation of brain and behavior research
Post Your Comments:
(Date:11/27/2015)... , ... November 27, 2015 , ... MPWH, the No.1 Herpes-only dating community in the ... Table 1-1 ). More than 3.7 billion people under the age of 50 ... (HSV-1), according to WHO's first global estimates of HSV-1 infection . , "The data ...
(Date:11/27/2015)... ... November 27, 2015 , ... A simply groundbreaking television series, "Voices ... show that delves into an array of issues that are presently affecting Americans. Dedicated ... open dialogue, this show is changing the subjects consumers focus on, one episode at ...
(Date:11/27/2015)... Los Angeles, CA (PRWEB) , ... November 27, 2015 , ... ... the Commission on Accreditation of Allied Health Education Programs (CAAHEP) awarded accreditation to its ... exclusive list of CAAHEP accredited colleges, as only one of twelve colleges and universities ...
(Date:11/27/2015)... ... November 27, 2015 , ... Avid collector, Andrew Hawley from Vintage ... style concert posters. This is one of Joplin's most famous and beautiful concert posters. ... University of Michigan in Ann Arbor. The According to Hawley, "It is hard to ...
(Date:11/26/2015)... (PRWEB) , ... November 26, 2015 , ... Inevitably when ... Many customers choose to buy during the Black Friday and Cyber Monday ... don’t need to search the Internet high and low to find the best massage ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... , November 26, 2015 /PRNewswire/ ... announced the addition of the  "2016 ... the Global Cell Surface Testing Market: ... report to their offering.  --> ... addition of the  "2016 Future Horizons ...
(Date:11/26/2015)... , November 26, 2015 /PRNewswire/ ... --> adds "Global ... and "Investigation Report on China Repaglinide ... 2021 forecasts data and information to ... . --> ...
(Date:11/25/2015)... DUBLIN , Nov. 25, 2015 /PRNewswire/ ... announced the addition of the "Global ... to their offering. --> ... "Global Brain Monitoring Devices Market 2015-2019" ... Research and Markets ( ) ...
Breaking Medicine Technology: